NCT03296670

Brief Summary

The study intends to evaluate the efficacy of different medicine delivering by targeted perfusion catheter in coronary administration on coronary blood flow in STEMI patients with CSFP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
Last Updated

March 12, 2020

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

September 25, 2017

Last Update Submit

March 11, 2020

Conditions

ST Segment Elevation Myocardial InfarctionCoronary Slow Flow Phenomenon

Keywords

STEMICSFPAlprostadiltargeted perfusion microcatheter

Outcome Measures

Primary Outcomes (4)

  • TIMI Flow Grade (TFG)

    TIMI Flow Grade (TFG)assesses flow in the epicardial arteries

    One mins after PCI

  • TIMI Flow Grade (TFG)

    TIMI Flow Grade (TFG)assesses flow in the epicardial arteries

    One mins after intracoronary medicine infusion post-PCI

  • TIMI Frame Count (CTFC)

    CTFC is a continuous measurement assessing flow in the epicardial arteries.

    One mins after PCI

  • TIMI Frame Count (CTFC)

    CTFC is a continuous measurement assessing flow in the epicardial arteries.

    One mins after intracoronary medicine infusion post-PCI

Secondary Outcomes (1)

  • LVEF by echocardiography

    Echocardiography was performed 3-7 days after PCI

Study Arms (2)

alprostadil

EXPERIMENTAL

alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Drug: Alprostadil

nitroglycerin

PLACEBO COMPARATOR

nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Drug: Nitroglycerin

Interventions

AlprostadilDRUG

alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

alprostadil
NitroglycerinDRUG

Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

nitroglycerin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patents with myocardial infarction who have symptom onset within 12h before randomization; ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ; Corrected TIMI frame counted (cTFC) measured from the final angiographic imaging after PCI exceeding 40 frames; Signed informed consent form prior to trial participation.

You may not qualify if:

  • Coronary artery bypass surgery (CABG) history; Failed in stents implanting; Severe heart failure; Cardiogenic shock.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University

Shanghai, China

Location

Related Publications (12)

  • Ding S, Pu J, Qiao ZQ, Shan P, Song W, Du Y, Shen JY, Jin SX, Sun Y, Shen L, Lim YL, He B. TIMI myocardial perfusion frame count: a new method to assess myocardial perfusion and its predictive value for short-term prognosis. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):722-32. doi: 10.1002/ccd.22298.

    PMID: 19960517BACKGROUND

  • Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.

    PMID: 19923168BACKGROUND

  • Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.

    PMID: 10637197BACKGROUND

  • van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.

    PMID: 9639373BACKGROUND

  • Chinese Society of Cardiology of Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guideline of non-ST segment elevation acute coronary syndrome]. Zhonghua Xin Xue Guan Bing Za Zhi. 2012 May;40(5):353-67. No abstract available. Chinese.

    PMID: 22883082BACKGROUND

  • Kidambi A, Mather AN, Motwani M, Swoboda P, Uddin A, Greenwood JP, Plein S. The effect of microvascular obstruction and intramyocardial hemorrhage on contractile recovery in reperfused myocardial infarction: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 Jun 27;15(1):58. doi: 10.1186/1532-429X-15-58.

    PMID: 23806080BACKGROUND

  • Roe MT, Ohman EM, Maas AC, Christenson RH, Mahaffey KW, Granger CB, Harrington RA, Califf RM, Krucoff MW. Shifting the open-artery hypothesis downstream: the quest for optimal reperfusion. J Am Coll Cardiol. 2001 Jan;37(1):9-18. doi: 10.1016/s0735-1097(00)01101-3.

    PMID: 11153779BACKGROUND

  • Pu J, Shan P, Ding S, Qiao Z, Jiang L, Song W, Du Y, Shen J, Shen L, Jin S, He B. Gender differences in epicardial and tissue-level reperfusion in patients undergoing primary angioplasty for acute myocardial infarction. Atherosclerosis. 2011 Mar;215(1):203-8. doi: 10.1016/j.atherosclerosis.2010.11.019. Epub 2010 Nov 26.

    PMID: 21176835BACKGROUND

  • Pu J, Ding S, Shan P, Qiao Z, Song W, Du Y, Shen J, Jin S, He B. Comparison of epicardial and myocardial perfusions after primary coronary angioplasty for ST-elevation myocardial infarction in patients under and over 75 years of age. Aging Clin Exp Res. 2010 Aug;22(4):295-302. doi: 10.1007/BF03337726. Epub 2009 Dec 1.

    PMID: 20009495BACKGROUND

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PMID: 21670242BACKGROUND

  • Shen LH, Wan F, Shen L, Ding S, Gong XR, Qiao ZQ, Du YP, Song W, Shen JY, Jin SX, Pu J, Yao TB, Jiang LS, Li WZ, Zhou GW, Liu SW, Han YL, He B. Pharmacoinvasive therapy for ST elevation myocardial infarction in China: a pilot study. J Thromb Thrombolysis. 2012 Jan;33(1):101-8. doi: 10.1007/s11239-011-0657-7.

    PMID: 22094974BACKGROUND

  • Sheng X, Ding S, Ge H, Sun Y, Kong L, He J, Pu J, He B. Intracoronary infusion of alprostadil and nitroglycerin with targeted perfusion microcatheter in STEMI patients with coronary slow flow phenomenon. Int J Cardiol. 2018 Aug 15;265:6-11. doi: 10.1016/j.ijcard.2018.04.119. Epub 2018 Apr 25.

    PMID: 29728334DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

AlprostadilNitroglycerin

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological FactorsNitro CompoundsOrganic Chemicals

Study Officials

  • Ben He, MD,PhD

    Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 28, 2017

Study Start

August 1, 2015

Primary Completion

April 28, 2017

Study Completion

August 31, 2017

Last Updated

March 12, 2020

Record last verified: 2017-09

Locations

CN(1)